From Form 10-K, Next Expected Milestones for Pa...
• We expect to submit regulatory filings with the EMA and Health Canada in the middle of 2014. If the EMA allows a filing that includes both the CF and NTM indication we will most likely submit our filing in the second half of 2014.
• We expect to evaluate our plans for this indication in the United States after reviewing the results from our phase 2 clinical trial in NTM.
• We are developing plans to commercialize ARIKAYCE, if approved, in certain countries in Europe and in Canada where we expect it would be the only once-a-day treatment for Pa lung infections in CF patients.